The condom, the pill and now, the smartphone? Natural Cycles, a mobile fertility app, this month became the first ever digital contraceptive device to win FDA marketing approval.
Women take their temperatures and track their menstrual cycle on the app, which uses an algorithm to determine when they're fertile and should abstain from unprotected sex or use protection. In effect, it's a form of the rhythm or calendar method.
The Swedish startup says it's effective and lets women avoid side effects common with other methods like birth control pills. But reports of unwanted pregnancies and investigations by authorities in two countries in Europe, where it received EU certification in 2017, have raised questions about marketing what is essentially a health monitor as a contraceptive.
Natural Cycles boasts more than 900,000 users, and such fast growth underscores risks for regulators and concerns among health professionals as they grapple with the rapidly emerging market for mobile and digital health applications.
"Apps are incredibly popular and there's nothing inherently wrong about using tech to support our health," said Bekki Burbidge, deputy chief executive of the Family Planning Association, a British sexual health organization.
"But they're also an area that is fairly unregulated and it can be hard to sort the good, evidence- and research-based apps from the bad."
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